11422 Federal Register / Vol. 73, No. 42 / Monday, March 3, 2008 / Notices 

For example, HRSA is interested in 

the public’s assessment of the likely 

impact if OPTN policies concerning 

issues such as membership designation 

to receive organs, the retrieval of organs, 

allocation of organs, data collection and 

reporting, and OPTN policy compliance 

oversight were extended to vascularized 

composite allograft transplants. HRSA 

seeks feedback concerning whether 

regulation under the OPTN final rule 

would be effective in addressing special 

safety and allocation issues presented 

by vascularized composite allograft 

transplants as the field grows. Further, 

HRSA is interested in the public’s 

assessment as to whether the clinical 

aspects of transplants of such 

vascularized composite allografts are 

more analogous to transplants of organs, 

as defined currently by the final rule, 

than to conventional tissue 

transplantation without surgical 

revascularization. 

Presently, it is HRSA’s understanding 

that these transplants of vascularized 

composite allografts are done by 

individual arrangements with local 

organ procurement organizations 

(OPOs) to allow retrieval of the needed 

structure during routine deceased donor 

organ retrievals. However, some of these 

vascularized composite allografts, e.g., 

testes, ovaries, or other endocrine 

glands, may come from living donors. 

HRSA is interested in perceived 

vulnerabilities concerning the current 

regulatory status of such transplants and 

the potential benefits of subjecting such 

transplants to the oversight of the OPTN 

and HRSA under the final rule. 

The Definition of Human Organs Under 

Section 301 of NOTA 

HRSA is also seeking feedback as to 

whether it should explore rulemaking to 

add vascularized composite allografts to 

the definition of human organs covered 

by section 301 of NOTA, as well as the 

potential consequences of such an 

action. Section 301 prohibits the 

purchase, sale, or other exchange for 

valuable consideration of human organs 

for transplantation. Although the statute 

lists covered human organs, the 

Secretary is authorized to add to this list 

through rulemaking. ‘‘Human organ,’’ as 

defined by NOTA and modified by the 

Secretary, means ‘‘the human (including 

fetal) kidney, liver, heart, lung, 

pancreas, bone marrow, cornea, eye, 

bone, skin, and intestine, including the 

esophagus, stomach, small and/or large 

intestine, or any portion of the 

gastrointestinal tract.’’ Adding to the 

definition of human organs covered by 

section 301 would make transfers of 

organs meeting the statute’s 

requirements subject to its criminal 

sanctions. If, after receiving public 

comments, HRSA is persuaded that a 

change to this definition may be 

appropriate, HRSA may initiate 

rulemaking setting forth a more specific 

set of proposals. 

Defining Vascularized Composite 

Allografts 

To assist the Secretary in the event 

that he proposes, through rulemaking, to 

add vascularized composite allografts to 

the definition of organs covered by the 

final rule and/or to the definition of 

human organs governed by section 301 

of NOTA, HRSA seeks feedback from 

stakeholders and from the public as to 

how such allografts should be defined. 

HRSA has identified two potential 

approaches. 

Under the first approach, a regulatory 

definition could be broad, describing 

the features of the allografts without 

listing particular body parts. Under such 

an approach, the definition might 

extend to transplants of body parts that 

are not known to have been performed 

clinically to date, or even to body parts 

whose transplantation has not yet been 

envisioned. HRSA is interested in what 

elements would need to be included in 

such a definition in order to be broad 

enough to cover the universe of 

intended body parts, but narrow enough 

to put the public on notice as to which 

parts meet the regulatory definitions of 

organs. Shared characteristics that might 

be included in a regulatory definition 

could include some or all of the 

following: (1) A vascularized allograft 

containing multiple tissue types; (2) 

recovered from a human donor as an 

anatomical/structural unit; (3) 

transplanted into a human recipient as 

an anatomical/structural unit; (4) 

minimally manipulated, as defined by 

FDA in Title 21 CFR 1271.3(f); (5) for 

homologous use as defined by FDA in 

Title 21 CFR 1271.3(c); (6) not combined 

with another article such as a device; (7) 

used fresh and not cryopreserved; (8) 

susceptible to ischemia and, therefore, 

only stored temporarily (e.g., cold 

storage in preservation medium and 

intended for implantation into a 

recipient within hours of the recovery); 

and (9) susceptible to allograft rejection 

which requires immunosuppression that 

may increase infectious disease risk to 

the recipient. HRSA seeks feedback 

from the public as to whether some or 

all of these characteristics describe 

vascularized composite allografts, 

which would be included in the 

definition of organ. HRSA invites 

feedback on such an approach as well 

as the particular characteristics listed 

here and invites suggestions concerning 

the advisability of including any 

additional characteristics. 

Under a second alternative, HRSA 

could propose a definition that lists 

specific body parts to be added to the 

definition of organs (e.g., face, hand, 

etc.). HRSA seeks feedback as to the 

feasibility of creating such a definition, 

which body parts should be included in 

such a definition, and whether such a 

definition would necessarily exclude 

certain body parts for which 

transplantation might be possible, but 

has not been performed to date (either 

in the United States or internationally). 

Following this comment period and 

meeting, if HRSA decides to proceed 

with rulemaking to include vascularized 

composite allografts in the definition of 

organ, this decision will be written and 

published as a Notice of Proposed 

Rulemaking. 

Dated: February 20, 2008. 

Elizabeth M. Duke, 

Administrator. 

[FR Doc. E8–3994 Filed 2–29–08; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications 

and/or contract proposals and the 

discussions could disclose confidential 

trade secrets or commercial property 

such as patentable material, and 

personal information concerning 

individuals associated with the grant 

applications and/or contract proposals, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel, 

Innovations in Cancer Sample Preparation. 

Date: March 20, 2008. 

Time: 8 a.m. to 8 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda Marriott Suites, 6711 

Democracy Boulevard, Bethesda, MD 20817. 

Contact Person: Sherwood Githens, PhD, 

Scientific Review Officer, Special Review 

and Logistics Branch, Division of Extramural 

Activities, National Cancer Institute, 6116 


rmajette on PROD1PC64 with NOTICES
Federal Register / Vol. 73, No. 42 / Monday, March 3, 2008 / Notices 11423 

Executive Blvd., Room 8053, Bethesda, MD 

20892, 301/435–1822, githenss@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel, Antibody 

Array for Cancer Detection. 

Date: March 26–27, 2008. 

Time: 9 a.m. to 5 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: Bethesda Marriott Suites, 6711 

Democracy Boulevard, Bethesda, MD 20817. 

Contact Person: Sherwood Githens, PhD, 

Scientific Review Officer, Special Review 

and Logistics Branch, Division of Extramural 

Activities, National Cancer Institute, 6116 

Executive Blvd., Room 8053, Bethesda, MD 

20892, 301/435–1822, githenss@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel, Cancer 

Stem Cells. 

Date: March 27, 2008. 

Time: 1 p.m. to 5 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 6116 

Executive Boulevard, Rockville, MD 20892 

(Telephone Conference Call). 

Contact Person: Irina Gordienko, PhD, 

Scientific Review Officer, Special Review 

and Logistics Branch, Division of Extramural 

Activities, National Cancer Institute, NIH, 

6116 Executive Blvd., Room 7073, Bethesda, 

MD 20892, 301–594–1566, 

gordienkoiv@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel, Portable 

Energy Balance Review Panel (PEBRP). 

Date: April 2, 2008. 

Time: 8 a.m. to 3 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: Bethesda Marriott Suites, 6711 

Democracy Boulevard, Bethesda, MD 20817. 

Contact Person: C. Michael Kerwin, PhD, 

MPH, Scientific Review Officer, Special 

Review and Logistics Branch, Division of 

Extramural Activities, National Cancer 

Institute, NIH, 6116 Executive Blvd., Rm. 

8057, Bethesda, MD 20892–8329, 301–496–

7421, kerwinm@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel, A webbased tailored health behavior intervention 

for African American colon cancer. 

Date: April 2, 2008. 

Open: 3 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda Marriott Suites, 6711 

Democracy Boulevard, Bethesda, MD 20817. 

Contact Person: C. Michael Kerwin, PhD, 

MPH, Scientific Review Officer, Special 

Review and Logistics Branch, Division of 

Extramural Activities, National Cancer 

Institute, NIH, 6116 Executive Blvd., Rm. 

8057, Bethesda, MD 20892–8329, 301–496–

7421, kerwinm@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel, 

Development of Clinical Mass Spectrometric 

Immunoassays. 

Date: April 3, 2008. 

Time: 11 a.m. to 5 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 6116 

Executive Boulevard, CR 6008, Rockville, MD 

20852 (Telephone Conference Call). 

Contact Person: Sherwood Githens, PhD, 

Scientific Review Officer, Special Review 

and Logistics Branch, Division of Extramural 

Activities, National Cancer Institute, 6116 

Executive Blvd., Room 8053, Bethesda, MD 

20892, 301/435–1822, githenss@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel, Network 

for Translational Research: Optical Imaging 

(NTROI). 

Date: June 2–3, 2008. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hilton Washington DC North—

Gaithersburg, 620 Perry Parkway, 

Gaithersburg, MD 20877. 

Contact Person: Kenneth L. Bielat, PhD, 

Scientific Review Officer, Special Review 

Logistics Branch, Division of Extramural 

Activities, National Cancer Institute, 6116 

Executive Boulevard, Room 7147, Bethesda, 

MD 20892–8329, 301–496–7576, 

bielatk@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel, Cancer 

Prevention Research. 

Date: June 17–18, 2008. 

Time: 7 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Renaissance M Street Hotel, 1143 

New Hampshire Avenue, NW., Washington, 

DC 20037. 

Contact Person: Irina Gordienko, PhD, 

Scientific Review Officer, Scientific Review 

and Logistics Branch, Division of Extramural 

Activities, National Cancer Institute, NIH, 

6166 Executive Blvd., Rm. 7073, Bethesda, 

MD 20892, 301–594–1566, 

gordienkoiv@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: February 21, 2008. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 08–906 Filed 2–29–08: 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the National Cancer 

Institute Special Emphasis Panel, April 

7, 2008, 8 a.m. to April 7, 5 p.m., 

Gaithersburg Hilton, 620 Perry Parkway, 

Gaithersburg, MD, 20877 which was 

published in the Federal Register on 

February 15, 2008, 73FR8886–8887. 

This notice is amended to change the 

name from ‘‘Biosensors for Early Cancer 

Detection & Risk Assessment/Novel & 

Improved Methods to Measure Cancer 

Epigenetic Biomarkers’’ to ‘‘Biosensors/ 

Cancer Epigenetic Biomarkers’’. The 

meeting is closed to the public. 

Dated: February 25, 2008. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 08–908 Filed 2–29–08; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Eye Institute; Notice of 

Closing Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

mended (5 U.S.C. Appendix 2), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in section 

552b(c)(6), Title 5 U.S.C., as amended. 

The grant applications and the 

discussions could disclose confidential 

trade secrets or commercial property 

such as patentable material, and 

personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Eye Institute 

Special Emphasis Panel, NEI Cooperative 

Agreement Review. 

Date: March 6, 2008. 

Time: 9 a.m. to 11 a.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 5635 

Fishers Lane, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Houmam H. Araj, PHD, 

Scientific Review Administrator, Division of 

Extramural Research, National Eye Institute, 

NIH, 5635 Fishers Lane, Suite 1300, 

Bethesda, MD 20892–9602, 301–451–2020, 

Haraj@mail.nih.gov. 

This notice is being published less than 15 

days prior to the meetings due to the timing 

limitations impose by the review and funding 

cycle. 

Name of Committee: National Eye Institute 

Special Emphasis Panel, NEI Cooperative 

Agreement Review. 

Date: March 20, 2008. 

Time: 12 p.m. to 1 p.m. 

Agenda: To review and evaluate grant 

applications. 


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